INTENDED USE

The CK-MB Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human CK-MB in whole blood, serum or plasma as an aid in the diagnosis of myocardial infarction (Ml).

SUMMARY

Creatine Kinase MB (CK-MB) is an enzyme present in the cardiac muscle with a molecular weight of 87.0 kDa. Creatine Kinase is a dimeric molecule formed from two subunits designated as “M” and “B” which combine to form three different isoenzymes, CK-MM, CK-BB, and CK-MB. CK-MB is the isoenzyme of Creatine Kinase most involved in the metabolism of cardiac muscle tissue.
The release of CK-MB into the blood following Ml can be detected within 3-8 hours after the onset of symptoms. It peaks within 9 to 30 hours, and returns to baseline levels within 48 to 72 hours. CK-MB is one of the most important cardiac markers and is widely recognized as the traditional marker for the diagnosis of Ml.
The CK-MB Rapid Test (Whole Blood/Serum/Plasma) is a simple test that utilizes a combination of antibody coated particles and capture reagents to qualitatively detect CK-MB in whole blood, serum or plasma. The minimum detection level is 5 ng/mL CK-MB.

PRINCIPLE

The CK-MB Rapid Test (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of CK-MB in whole blood, serum or plasma. The membrane is pre-coated with specific capture antibodies in the test line regions of the test. During testing, the whole blood, serum or plasma specimen reacts with the particle coated with specific antibodies. The mixture migrates upward on the membrane chromatographically by capillary action to react with specific capture reagents on the membrane and generate a colored line. The presence of this colored line in the specific test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control,a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.